Q2 2022 Myovant Sciences Ltd Earnings Call
[music].
Okay.
Good day, everyone and welcome to my event Sciences' second quarter of fiscal year 'twenty 'twenty. One earnings conference call. Today's call is being recorded at this time I would like to turn the call over to Ryan Crowe, Vice President of Investor Relations.
Please go ahead.
Yeah.
Thank you operator, good morning, and thanks for joining us today to review the financial results of my events second quarter of fiscal year, 2021, and to discuss other corporate and business updates.
Joining me for today's call are Dave Marek <unk>, Chief Executive Officer unique marrow, Chief financial and business Officer, Lauren Berandino, Chief Commercial officer, and Dr. Juan Camilo Arcana, Chief Medical Officer.
In addition to the press release issued earlier today the slides that will be presented during today's webcast are available on our investor Relations website investors <unk> Dot com.
Today, we will be referring to our fiscal second quarter, which ended on September 32021 is our second quarter or Q2 throughout this presentation.
During the course of this conference call, we will be making forward looking statements.
These include plans and expectations with respect to our products product candidates strategies opportunities and financials, all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
A discussion of these risks can be found in our SEC disclosure documents.
<unk> My event does not undertake any obligation to update any forward looking statements made during this call.
I'll now turn the call over to Dave Merrick My events, Chief Executive Officer, Dave.
Thank you Ryan and good morning, everyone.
During our second fiscal quarter miles and continued to make significant progress with our U S launches of <unk> in my February in addition to achieving an important clinical and regulatory milestones, which position <unk> for long term success.
My event recorded $77 9 million of total revenue in the quarter, including $21 1 million of net product revenue.
<unk> achieved net revenues of $18 $7 million in its third quarter on the U S market, reflecting 78% sequential growth compared to fiscal Q1.
And its first full quarter on the U S market. My February achieved net revenues of zero point $6 million, primarily reflecting a continuation of initial inventory stocking.
From a launch execution standpoint, we've made meaningful early progress educating prescribers about our differentiated clinical profile.
Reaching initial patients.
Establishing payer coverage all of which are foundational to my <unk> long term success.
Moving to clinical and regulatory updates.
During Q2, the European Commission, and the UK medicines and healthcare products agency approved <unk> as the first and only long term once daily oral treatment for uterine fibroids.
For my summary, we were pleased that the FDA accepted our supplemental new drug application seeking approval for the management of moderate to severe pain associated with endometriosis.
We expect a decision from the FDA at the May six 2022 Paducah date.
And FDA approval for this indication would trigger a $100 million milestone payment from Pfizer, while providing a meaningfully different therapeutic option for women with endometriosis.
Last week mile then and Pfizer presented clinical data from my memory at the American Society for reproductive Medicine, 2021 Congress.
In addition to the results of the Liberty randomized withdrawal study and the Spirit studies in Endometriosis. We also presented pooled safety and Tolerability data from the spirit and Liberty programs, which demonstrated a consistent profile across women with uterine fibroids and women with endometriosis.
Providing further support of our one brand one pill once a day approach to treating these conditions.
Quality of life data in women with Endometriosis was also presented which demonstrated that significantly reducing endometriosis pain was associated with improvements in daily functioning emotional wellbeing self image and sense of control.
Finally in August.
D. A lifted its partial clinical hold for the phase III Serene study of my February to evaluate prevention of pregnancy, and we're pleased to have recently dosed our first patients under the amended protocol.
Upon notification of the partial clinical hold in May we not only address the fda's requirement for bone mineral density monitoring.
But worked closely with them to further optimize the design of the serene study to gain incremental safety and efficacy data in patient populations with the greatest potential to benefit from my memory.
The primary analysis of the study prevention of pregnancy remains unchanged, but now it's serene will focus on only evaluating women with a confirmed diagnosis of uterine fibroids or in Dmitry doses.
P M D monitoring will occur during the treatment period as well as after discontinuation, which will augment the profile observed in the Liberty and spirit programs.
The enrollment target was increased to 1020 patients who are 18 to 50 years of age and at risk of pregnancy enhancing the power of the study.
Serena is the first study of its kind in this class of medicines and a positive result could expand my family's prescribing information to include a prevention of pregnancy indication.
This would further support clinical differentiation and bring meaningful additional benefit and convenience to women with uterine fibroids and endometriosis.
Turning to business development and financial updates today.
Today, we announced that Pfizer declined to exercise its option for development and commercialization rights to <unk> and oncology and international markets.
Based on discussions with Pfizer their decision was not related to clinical or anticipated regulatory considerations for <unk> and oncology.
But rather was based on their assessment of their current strategic investment priorities and international markets.
I would underscore that it has no impact on our collaboration in the U S and Canada, particularly given the aerobics and then my fabri launches are off to a great start in large part due to our collaborative efforts to date.
Over the months, leading up to Pfizer's decision, we received inquiries regarding this opportunity from multiple interested parties.
We are currently assessing these opportunities focusing on potential partners with an established European commercial presence in neurology or oncology.
Our goal is to reach agreement with a partner by the anticipated European approval of rail you've got looks for prostate cancer expected in mid 2022.
In the meantime, we continue to work with the MAA through.
Ongoing review process.
And on other prelaunch activities related to pricing and reimbursement. So our chosen partner will be in a position to execute a launch shortly after regulatory Lee after regulatory approval.
Regarding financial updates last month, my old man appointed unique Mirra, two chief financial and business Officer.
Unique leads mild ant finance alliance partnerships and business development functions and as a member of my Executive Committee reporting to me.
For those of you who have not met unique he brings extensive financial and leadership expertise supporting multibillion dollar commercial stage businesses. In addition to deep experience successfully growing and scaling emerging companies and we are delighted to have unique on the mild and team.
We continue to be in a strong financial position to support the launches of <unk> in my February while seeking to expand our pipeline.
As of September 30th miles had cash and committed financing of over $650 million.
We are encouraged by the commercial momentum for or go VIX and the early launch progress for my Fabry.
Together with our recent notable clinical and regulatory achievements miles is well positioned for strong commercial execution and sustainable long term growth.
Now for a more in depth review of our commercial performance I'll turn the call over to Laurent.
Thank you Dave.
Today I'll provide an update on the progress we've made on the or go back to my somebody launches in the U S.
Well go that's adoption continues to build as we and Pfizer worked towards establishing it as the new androgen deprivation standard of care.
Nine months into our launch we have recorded nearly $33 million of net revenues and estimate that approximately 8000 men had been treated with oral <unk>.
In fiscal Q2, well go that's generated $18 $7 million of net product revenues, reflecting 78% sequential demand driven growth compared to fiscal Q1.
This continued momentum for them, though that's reflects increasing patient and clinician demand for its differentiated clinical profile as well as expanding payer coverage.
Monthly estimated cumulative patients on therapy, which includes both patients on free and commercial drug has continued to steadily increase month over month.
Through September we estimate that approximately 8000 men have initiated or go this therapy for their advanced prostate cancer.
The share of free drugs from our free trial bridge and patient assistance programs continues to represent approximately one third of total or clothing volume dispense to date.
Although our visibility into patient level data is incomplete, we continue to estimate that approximately 60% of our patients that have initiated or go they were previously naive to ADT.
Additionally, based on our market research, we believe that although that is being utilized to treat patients across the spectrum of advanced prostate cancer.
Reflecting our broad FDA label and the therapeutic appeal of the ARX <unk> clinical profile, regardless of disease setting.
Since launch we have been actively engaging with prescribers to drive awareness and build recognition of its differentiated clinical profile.
In the first nine months of launch my that and Pfizer have conducted sales calls with over 17000 unique providers.
These sales efforts are delivering results.
As you can see from the chart on the left we have steadily broadened the base of prescribers to approximately 1500 treatment centers through September and.
An increase of approximately 350 over the past three months and nearly doubling since April.
These numbers include accounts that aren't expensing or prescribing orthotics.
The order rate in these treatment centers also continues to build with nearly 90% of practices reordering or go away at least once up from 80% at the end of June.
Our launch activities to date have intentionally focused on tier one customers to maximize impact on prescribing and we have reached 92% of these high priority target prescribers.
So I'm a treatment center standpoint, nearly three out of four tier one urology practices with in office dispensing capabilities have dispensed or globex, while just over half of tier one oncology I O D practices have defense or buybacks.
We are proud to have achieved broad coverage for I'll go back in advance of our calendar year end 'twenty.
<unk> 2021 goal.
Through October 1st we have achieved coverage for over 173 million total lives and increase of 23 million lives since July 1st.
Nearly all of these incremental covered lives where for commercial plants, where we improved from 63% coverage in July to 76% as of October.
Looking ahead to 2022, we expect broad commercial and part D coverage for our buildings to continue.
We are making tremendous progress across all areas of the oil goes X launch and have built great momentum in the prostate cancer community.
As we look forward, we will continue to engage with neurologists and oncologists to expand breadth and depth of our globex prescribing.
Improved commercial and part D coverage as well as an increasing engagement directly with patients is expected to drive prescribing momentum in coming quarters.
My dad, and Pfizer remain committed to improving the lives of men battling advanced prostate cancer and over time steadily establishing or go back as the new standard of care a D T.
I'd now like to discuss the early progress we've made on the my son relaunch.
The FDA approved my family in late May 2021 as the first and only once daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in pre menopausal women.
My memory has the potential to redefine care for these women because its clinical profile aligns with physician stated treatment goals.
The Liberty clinical program, my Fabri demonstrated sustained and meaningful reduction in menstrual blood loss.
Hot flush I, particularly bothersome side effect occurred in less than 11% of my fabry patients not meaningfully different than the approximately 7% of patients treated with placebo.
The average decline in lumbar spine bone mineral density at 12 months was under 1%.
Due to the risk of continued gone loss the duration of use and the FDA label is limited to 24 months.
Finally, my Fabri achieved all of this in one small pill taken just once a day.
We launched my Fabri with Pfizer in mid June with a comprehensive focus across providers patients and payers.
Together, we've made encouraging progress in these early days and believe we're on the right track towards laying the groundwork for a long term commercial success.
We fully expect that it'll take time to change behavior for the treatment of uterine fibroids.
The Mylan and Pfizer sales teams have been very active in the first four months of the launch educating providers on the clinical profile and the convenience of my summary.
We have also ramped up our starter program, which is designed to give providers a seamless initial prescribing experience.
Our patient support programs are designed to facilitate access to my memory.
These resources include benefits investigation.
Authorizations and appeals support.
Starter and bridge programs.
Co pay support for commercially insured patients.
And patient assistance for qualifying uninsured patients.
Over time, we also expect to drive my family product awareness through various channels with the goal of activating women with symptomatic uterine fibroids.
Finally with payers our goal is to establish broad coverage quickly within a year of our launch let's review our progress across each of these areas.
One key priority for our launch is provider education, which can have a significant impact on awareness.
Since launch the Mylan and Pfizer sales teams have conducted 62000 calls, reaching 77% of our high and medium priority target prescribers.
This activity has improved aided awareness among potential prescribers from approximately 30% prelaunch to nearly 70% as of September.
Unaided awareness has also improved remarkably.
With more than one in four target prescribers now able to identify the my son rebrand.
For high and medium decile target providers, where we have primarily focused our initial education efforts unaided awareness has grown to approximately 40% in just three months.
Through September 30th approximately 600 women have initiated treatment with my family.
Which includes patients both on free and commercial drug but does not include patients that may be using product samples.
Another important leading indicator for my summary treatment initiation is the number of patients actively enrolled in the my fabry patient support hub.
There are currently approximately 100 patients in our hubs that are pursuing therapy, but either require assistance navigating coverage and reimbursement or seeking copay assistance or are applying for a bridge program.
Well many of these patients are likely to initiate treatment on free drug we expected my fabry treatment experience will be positive and that most patients will convert to commercial volumes overtime once coverage and reimbursement improves.
Finally starter packs or product samples are an important part of our early launch strategy.
We want providers to have a seamless initial treatment experience with my family when a woman presents with heavy menstrual bleeding from uterine fibroids.
Since mid July we have distributed over 3000 months of therapy via starters to over 2200 gynecologist around the country.
While we recognize these samples may depress, new prescription volume and revenues in the near term.
We view product samples like a long term investment in the brand and are confident that these samples will ultimately accelerate adoption by generating a positive initial treatment experience for providers and patients.
From launch through the end of Q2, we recorded $1 $7 million of that revenues, including approximately $600000 in Q2.
As expected we saw continuation of initial inventory stocking early in the quarter and began to see modest demand driven reorders to replenish launch inventories beginning in September.
We continue to anticipate gradual adoption over the next few quarters as we execute our launch plan and laid the foundation for long term commercial success.
Obtaining payer coverage for my Fabry is a critical launch priority.
Given we anticipate that approximately 85% of patients that could be prescribed my fabri are commercially insured. Our initial focus has been on securing coverage with large commercial pharmacy benefit managers.
We're off to a great start as of October as we have achieved coverage for my fabri for 61% of commercial lives.
Negotiations are ongoing with additional commercial payers.
That have yet to make coverage decisions and we expect coverage to improve in the coming months.
Payer negotiations are focused on maintaining prescriber choice and minimizing out of pocket cost for patients.
My son bring addresses the needs of providers and patients with its clinical profile and convenient one pill once a day dosing.
We are excited about the progress we have been able to make in these early days of launch and remain passionate about bringing this new and differentiated treatment option to women with uterine fibroids.
I'll now turn the call over to unique to review our financial results unique.
Thank you Lauren.
I'm excited to be joining marathon at this pivotal stage of growth for the company and to be supporting its critical mission affirmative finding care for women and for men.
My comments today will focus on the highlights of our financial performance in the second fiscal quarter ending September 2021.
Please refer to our press release and Form 10-Q issued earlier today for additional information.
Let's begin with revenue.
My rent recorded $77 $9 million of total revenue for this quarter.
Q2, net product revenue totaled $21 $1 million.
Our <unk> net revenues were $18 $7 million.
<unk> strong sequential demand.
Actually offset by an expected decrease in net price due to a higher gross to net discount compared to Q1.
We expect gross to net discount will continue to increase in coming quarters, reflecting the impact of rebates for incremental covered lives before stabilizing in 2022 went to commercial and part D coverage has been fully implemented.
My family net revenues were $6 million, primarily reflecting continuation of initial inventory stocking.
Modest demand driven reorders to replenish launch inventories began in September 2021.
New this quarter, we recorded $1.8 million of product revenues from Gideon Victor.
Primarily from radical product to play and to a lesser extent royalties.
Moving forward my rent is entitled to receive tiered royalties on net sales of radical ranging from mid teens to mid 20%.
We also recorded $25 $2 million of Pfizer collaboration revenue.
Listing of $21 million related to the partial recognition of the upfront payment my rent received from Pfizer in December 2020, and $4 $2 million related to the partial recognition of 100 million regulatory milestone payment triggered upon.
Upon FDA approval of my family for uterine fibroids.
In future quarters, we will continue to amortize. These milestones at these same amounts through the end of calendar year 2026, when the amortization period is get used to it.
Finally, we also recorded $31 $7 million of license and milestone revenue from Gedeon Richter.
Oh for $15 million regulatory milestone payment for the EC approval of radical for uterine fibroids and $16 7 million related to the remaining portion of the upfront and initial milestone payment.
Moving on to the other.
Highlights of our income statement.
Buster product revenue for the quarter was $2 $6 million and largely comprised of the royalty on net sales of really really stable.
Babies with Takeda and to a lesser extent expenses related to the cost of goods sold.
Collaboration expense was $8 $6 million, reflecting pfizer's, 50% share of net profits from sales of Covid and my family in the U S. During Q2.
R&D expenses in the second quarter were $26 $3 million compared to $45 million for the comparable prior year period.
The decrease in R&D expenses were mainly driven by cost sharing reimbursements from Pfizer as well as a reduction in clinical study costs.
These decreases were partially offset.
Mainly by higher expenses in good, but my rent Medical Affairs organization.
SG&A expenses in the quarter were $58 $8 million compared to $31 $3 million for the comparable variety of period.
The increase was primarily due to higher expenses related to commercial activities.
Both the U S launches of our colleagues and my family and higher personnel related costs in connection with the hiring of my went to commercial operations marketing and market access teams as.
As well as the quality and women's health sales forces.
Myelin generated a net loss of $21 $6 million or 23 cents per share in the second quarter of 2021 compared to a net loss of $67 $1 million or 75 cents per share in the prior year quarter.
Looking ahead.
<unk> expenses for the remaining fiscal 2021 quarters are projected to be in line with Q2 actual spend.
SG&A expenses for the remaining fiscal 2021 quarters I'd expect it to increase modestly from Q2 actual skin.
We ended fiscal Q2 with total cash marketable securities and committed financing of $657 $3 million comprised of $616 million of cash and marketable securities and $41 $3 million of.
The remaining under the low cost loan facility extended to us by Sumitomo Dainippon pharma our majority shareholder.
Our cash position and potential future milestone payments, coupled with the shedding of certain expenses with Pfizer and the anticipated increase in Ogilvy and my family's revenues puts my rent in an excellent position to execute our commercial strategies, while at the same time expanding our pipeline.
Through future available ex lifecycle programs and potential business development.
With that I'll turn it back over to Dave for some closing remarks, Dave.
Thank you unique in Lora.
We are excited about the launch momentum that we've been able to generate for COVID-19.
There is increasing recognition by clinicians regarding its differentiated clinical profile, which is leading to steadily increasing adoption.
Over the past few months, we were able to improve commercial payer coverage and are in a very strong position as we finish 2021 and move into 2022.
We've been encouraged by the early progress that we've made on the my February launch and look forward to continuing to build the foundation for successful commercialization through prescriber education.
Access with expanded payer coverage and engaging directly with patients.
February is a significant advance for the treatment of heavy menstrual bleeding associated with uterine fibroids and with time, we believe will represent a significant commercial opportunity.
The Serene study resumed in August with an updated clinical protocol that will evaluate prevention of pregnancy, while gaining incremental safety and efficacy data in patients with the greatest potential to benefit from my fabri therapy.
We dosed, our first patient last week and look forward to advancing the study as quickly as possible.
In addition to continuing to execute on the ore go VIX in my February launches Milden has several important upcoming clinical and regulatory milestones.
By late 2021 or in Q1 2022, we plan to submit a randomized withdrawal study to the FDA, which will include two year bone mineral density data.
In Q1 2022, we expect to report two year data for the Spirit long term extension study for my son, Brea and women with endometriosis associated pain.
Additionally, we expect to receive an FDA decision on the my Fabri Endometriosis S. NDA filing by its May six Paducah date.
Richter is expecting to file for EU approval of re echo in endometriosis next year.
Finally, we expect the European Commission's decision for a prostate cancer filing in mid 2022.
We continue to operate from a position of financial strength, giving us the flexibility to sufficiently fund our U S product launches, while expanding our pipeline through well you go with lifecycle opportunities and potential business development.
I'm extremely proud of the passion and the work done by our mile that team to enable us to deliver on our mission to positively impact the lives of so many men and women.
Thank you for your attention and I'll turn it over to Ryan to begin the Q&A session.
Thank you Dave operator can we now please poll for questions.
Thank you to ask a question you will need to press Star then one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.
Our first question comes from the line of Brian Corny with Baird. Your line is now open.
Hey, good morning, guys. Thanks for taking my question I guess my first question is just thinking about the EU opportunity with the.
The approval potentially come in mid next year is your expectation that you would have a partner ahead of approval now or is there any inclination towards building any infrastructure to launch on your own in the EU.
Yeah. Good morning, Brian. Thank you for the question because we have multiple interested parties in our next step will be really to initiate a formal process, where we will select.
We believe would be the ideal partner. We can currently are not building infrastructure for launching in Europe, and then we feel confident with the interest that we've received that we intend to have a partner in place in time for the launch.
Great and then if I could just ask one other question I was hoping you could kind of contextualize the conversation that you're having with payers and pbms.
Sort of the differences in those conversations between ortho VIX in my family I mean, it just seems like the only thing that one needs to do to convince them of the value for or going back to just the oral to get coverage, but how about your discussions going with regards to the competitive dynamic with or less I understand it's pretty early but our payers I'm looking to.
Any exclusivity here at all our Payors.
Would you expect they would generally reimbursed both them and us getting the endometriosis in the endometriosis label critical to driving better coverage since we're a lessor currently houses both indications.
Yeah, Brian I'll, let Lauren weigh in here I would just say from a top line perspective, you know our philosophy is to work with payers to grant.
Much access to patients as available and then let the decision really reside from a clinical perspective with the clinicians themselves.
Whether that sort of go away sort of my family, but let me turn it over to Loren to address the crush more specifically.
Yes, good morning, Brian.
From a from a payer discussion perspective, we really focused on seeking parity coverage.
For my summary, as Dave mentioned, we believe it's important for physicians to have a choice and we believe when they have that choice that my summary, well well.
We will likely be their choice.
So so so that's how our conversations have been going with it.
Payers and some of those parents have asked us if we would be interested in an exclusive option. Obviously that comes with greater discounts and then year over year creates a competitive environment.
Repeated discounts so that has not been our strategy, we really kept those conversations to parity discussions and that's what we've been successful in securing so far.
Great. Thanks.
And one thing to add this is Juan Camilo I just want to qualify based on your question of that.
The.
For endometriosis or Lisa.
Bad debt for uterine fibroids, which is orient. So all the conversations that Lori just mentioned, it's about orienting uterine fibroids, but.
We do believe that once we are able to if we get approval by the FDA, having both indications in one single label will be.
Well it'll be to our advantage.
Yeah.
Our next question comes from the line of Phil Nadeau with Cowen your.
Your line is now open.
Good morning, Thanks for taking our questions and congrats on the progress first on the ex U S partnership just to follow up on Brian's question I know you mentioned during the prepared.
Prepared remarks that you hope to find a partner that has established infrastructure in urology and oncology.
What are the priorities do you have and.
And finding that partnership how much how do you weigh for example established infrastructure.
Now mix there'll be offered to you.
Yes. Thank you Bill our intention is to ensure that.
As to the patients who we believe are in great need in the European market and so we'll look for a partnership that has the breadth to enable two different.
We'll go next to the right patients.
Of the things that's helpful. As an established infrastructure in oncology or urology is already in place.
Rather than needing to build out from the ground up.
And then of course, we'll look at the financial terms that we think will be mutually beneficial and particularly beneficial to model that.
Perfect and then just a couple of questions on the watches here in the U S. On our Globex do you have any sense for the duration that men, who remain on therapy or is it still.
Too early in the launch to really understand how it's being used in the in the men's specifically.
Yes.
We just don't have enough data that we feel like we can kind of band on one.
Kind of duration of therapy is I think we've described in other settings. We do have a variety of patients patient types that are being prescribed aerobics, but we haven't landed on a specific duration given the 10 years that we have on the market and the limited data that we have to view.
Great and then last question on that my friend very much your statistics on the aided and unaided awareness My February are interesting.
Hum anecdotal check suggest that.
That the awareness of generic class the oral Gnrh class is actually relatively low given how long her hand and her list has been on the market. What is your market research suggests that about the awareness of the overall class. The fact that oral gnrh antagonist are actually.
Option is that is that awareness, where you would think it would be or is it significantly lower.
Given how long the class has been on the market.
Yeah, I'll, let Lauren take that part.
Yeah. So from an awareness perspective, we do see that awareness of the class is is higher than my summary alone.
But to your point I think the real competition here is not in class competition. It is changing the mindset of physician from their standard of care, which is those scenes and surgery and many of them have been doing this since they started as do I and then it's deeply ingrained and so.
That's what we really need to break through and so our intention beyond just.
Speaking to my summary.
<unk> is also to expand the understanding of the disease the impact on patients and and how.
The gnrh products can can help Ah.
Patients beyond overseas and surgery.
And I think the one of the.
Areas that we can really help us the join field force efforts that we have so not only do we have our field force for value add.
These are as you know from the very initial stages and then as Lauren has mentioned in other forums.
Our expectation that we will begin engaging patients at the appropriate time as well in a more fulsome way. So do you believe that those are all areas that will increase the recognition of my memory, specifically, if we think that that's really going to be.
A great set up for it and we've also seen a shift with the a cod guidelines and for that I'll turn it over to one mill.
Yeah. Thanks, Steve Yeah, we're excited about the recent update to the ankle guidelines for the treatment of heavy menstrual bleeding and uterine fibroids, where whereas Thornton was pointing out the patient perspective as is highlighted as something that physicians should consider and enjoying decision making at the <unk>.
Patients should be offered all the options.
And there's a new guideline and also highlights the importance of the addition of Gnrh.
Antagonist.
The treatment option.
And Furthermore, it.
It does not the trim and lines of therapy removes contraceptive. That's the first line and encourage physicians to provide all the options to patients. So that that joined decision making can take place. So we the thing we think all of that.
Is that changing the landscape in favor of oral therapies, and we believe that the my family profile is going to be successful in that setting.
That's very helpful. Thanks for taking our questions.
Yeah.
Yeah.
Our next question comes from the line of around a relaxed with SBB Leerink. Your line is open.
Hi, Thanks for taking the question.
For Argo VIX I was curious if you could give some detail on the ongoing prescribing trends between oncologists and urologists and has the per cent per cent split between these prescribers are changed at all since last quarter.
Alright.
Yeah. Thank you for the question. So the the ratio has not changed so we continue to see about 60% of our Oracle of its volume coming from urologists and roughly 40% from oncologists.
Okay, Great and then for my son Brie I was curious if you could talk a bit about how physician uptake is progressing and I noticed you mentioned that there was some inventory stocking and I was wondering how that's layering into the prescribing trends Youre seeing I know, it's very early days and maybe could you remind us.
How aggressive are you being with the free drug program at least at the outset.
Yes.
Yeah, that's a great question so I'll.
I'll start with your last question first around free products. So as we mentioned first experience is really important in this market and so we have invested in multiple programs to provide support to patients upfront. These include free drug programs and we also have launched a sample.
Program, so none of the free drug programs or the sample program will be included in any of the data that any of the prescription data that that we see and so that's an important point because.
We are the first to watch for samples.
In this in this class so so that.
May result in some differences in being able to estimate the demand.
However, we think that that short term.
Delay in starting commercial product is actually worth it in the long term because it provides an opportunity for physicians to get experience with the product for patients to see the efficacy of the product and builds confidence over time and in my family overall.
Okay got it and then the dynamics of inventory stocking as well.
Yes, So we had initial inventory stocking in June and.
Running into July and that was as expected. It was just at the levels that we expected and then since.
Since then and as we mentioned in our last call and they need to burn through the inventory in the channel before starting to reorder and we've now started to see some reorders.
In September that are based on on the demand.
Great. Thanks.
Thank you.
Our next question comes from the line of Gavin Clark Gardner with Evercore ISI. Your line is open.
Hey, Thanks for taking my questions. Congrats on a good quarter. So I have two.
First roughly how is your SG&A split between a prostate cancer in women health today is that likely to change moving forward, including with the endometriosis lunch and then secondly under the Pfizer partnership you have the ability to invest more or less heavily in either franchise, specifically and what went to decision.
<unk> process look like.
Yeah.
All that you need to take the SG&A split the questions and then we'll cover by.
Thanks, Kevin I think Andy as you know.
He has played right now it's too early for us in terms of human blood lines, because we need to fund appropriately their booth at an exciting stage of the launch.
Cumulatively you've seen.
We have spent I mean, it was in line with what we spend.
Spend in Q1, we continue to hope we continue to make sure that both of these brands are adequately funded from an SG&A perspective and that right now the.
The split activity.
So if you're listening to.
Runs of planning for endometriosis that potentially could come down the line.
And Gavin I think over time on the.
Memory side, certainly we have mentioned before that that it will keep an eye on appropriate spend for consumer awareness and engagement.
But we'll do that in a very.
Physically.
Savvy way to ensure that we're leveraging digital technologies et cetera, and in order to reach women.
Turning to Pfizer relationship, we have a preset agreements on guardrails around spending.
Should we decide that we want to change those are re a portion of those we have every option to sit down with Pfizer and then make sure that we're putting the appropriate.
And against both franchises and as you know we're both very interested in the success of both in February and or Goldman equally. So we'll make sure that we can continue to keep those dialogues are running with Pfizer. So below franchises are fully funded.
That's helpful. Thanks.
Thank you.
As a reminder to ask a question you will need to press Star then one on your telephone.
Our next question comes from the line of Madhu Kumar with Goldman Sachs. Your line is now open.
Hey, everyone. Thanks for taking our question so kind of thinking about the business development aspect.
What kinds of opportunities are you looking for and when do you think we'll have a sense of visibility on potential kind of in licensing potentially of products that could be distinct from the value of golar franchise.
Thank you Madhu.
Unique take that yeah. Thanks Madhu.
But the things we are focused on business development opportunities related to Madhu adjacencies to our current therapeutic areas. So just to give you a perspective I think of Volatilities in women's health would be a natural fit that he would consider given our presence in prostate cancer as it is a potential lifecycle opportunities for <unk>.
Beyond prostate cancer, urology and oncology, there's also a potential area of interest for us from a timing perspective, I think look we're taking a very prudent and thoughtful approach to any potential future business.
Our productivity and we were thinking that holistic view in addition to the current lifecycle newpage entity as we have with the reservoir.
Franchise as well.
Okay and following from that are there any technologies you'd be particularly focused in in those types of indications pieces or is it really more of a kind of best athlete kind of mentality, where the best drug you can find independent of a modality our technology approach.
Yeah, it's a good one.
Think about that all those technologies that help us enable our current offerings in the market or help us augment those I think would be in a line of sight right now and I think as you know there potentially.
Knowledge is changing pretty rapidly at all and so we have a very.
Focused look into several of these technologies right now to help us improve our current offerings.
Great. Thank you very much everyone.
Yeah.
Our last question comes from the line of Eric Joseph with Jpmorgan. Your line is now open.
Hi, Good morning, Thanks for taking my questions just a couple of commercial ones from us.
Thanks.
Noticing that as volume demand grows youre, maintaining a pretty steady city.
Steady rate of patient access.
Free drug.
Are getting access to drug VP of free drug programs and about a third I guess can you talk about the proportion of patients on free supply that converts a paper products and I guess, how long that takes and do you have a sense of where that.
Where that breakdown ratio might go into.
Into next year.
And then just coming back to early trends of my February just.
Looking to hopefully get a breakdown of <unk>.
Patients that are on page four versus free drug and similarly, there just curious to know expectations around the conversion rate.
Moving on three supply converting to paper products. Thanks.
Yes.
Thank you for the questions Eric.
<unk> addressed those.
Thank you Eric.
So from a free trial perspective on or go backs.
Kind of a distribution model, we don't have clarity into conversion so I'm.
As you know much of our drug is dispensed through in office dispensing and so we only see bottles, we can't tie it to a patient and so we don't have data on the rate of conversion or speed of conversion as a result.
Yeah, and I also think relative to <unk>.
Can you you mentioned the proportionality of free goods to being that were about the same as what we saw last time through as well.
And then I think that's the kind of the gap between the coverage, we've received and that coverage infill trading into the minds of our subscribers. So I think prescribers are still leaning into the free goods program as we're continuing to communicate these advances that we've made in coverage and that's just.
With time.
Making progress in getting the word out so to speak but that does take time and then a more I'll. Let you address the <unk> question as well, yes. So some of my summary perspective, the majority of patients are on commercial drug.
However, we arent able to estimate how many patients are on samples we know how many samples we distributed although we don't know how many samples had made it into the hands of patients, but the patient numbers that we shared in the presentation include both commercial patients as well as those on our free drug programs through our hub and so.
That case, the majority of those patients are commercial.
Okay.
It does.
The free drug programs.
Turn loaded in any way I know.
There's probably some.
Supply available beyond just the starter packs for both products are they.
I guess two limited however.
Sure.
You mean, you mean, how long a patient can stay on the free program is that what your question is.
Correct.
Yeah. So so each program has a slightly different duration, but outreach programs.
M a R.
And so our bridge program has two months.
Four.
For government pay patients, which actually is not called it's called the bridge program and patient assistance program.
Hum.
And then the painful the patient assistance program is a long term program for uninsured patients. So that one does not have a duration or duration.
But we have to bridge programs, one quick one for commercial and one for <unk>.
Hum.
Hum.
Government Ah patients and and those are two to four months.
And then our free trial program on or go VIX is up to four months.
Yes.
Okay, Okay, great. Thanks for taking the questions.
Okay.
Thank you there are no further questions I will now turn the call back to Dave Merit for closing remarks.
So clearly we're very encouraged by the progress that we've made.
And in my February launches and enabling our mission of redefining care for women and for a minute.
<unk> remains well positioned both operationally and financially to deliver strong commercial execution and to build sustainable long term value. Thank you and I look forward to keeping you updated on our progress.
Ladies and gentlemen, this concludes Mario Van Sciences' second fiscal quarter 2021 earnings Conference call. Thank you for your participation you may now disconnect.
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